Egrifta Wr Generic Name & Formulations
Legal Class
Rx
General Description
Tesamorelin 11.6mg; per vial; lyophilized pwd for SC inj after reconstitution; preservative-free; contains mannitol.
Pharmacological Class
Growth hormone releasing factor analogue.
How Supplied
Egrifta WR—4 (vials w. diluent + supplies); Egrifta SV—30 (vials w. diluent + supplies)
Storage
Store at room temperature at 20°C to 25°C (68°F to 77°F) in the original box to protect from light; excursions permitted to 15°C to 30°C (59°F to 86°F). Do not freeze.
Generic Availability
NO
Mechanism of Action
Tesamorelin binds and stimulates human growth hormone-releasing factor (GRF) receptors with similar potency as the endogenous GRF. Stimulates growth hormone secretion, and subsequently increases IGF-1 and IGFBP-3 levels.
Egrifta Wr Indications
Indications
For the reduction of excess abdominal fat in HIV-infected adults with lipodystrophy.
Limitations of Use
Long-term cardiovascular safety has not been established. Not for use in weight loss management. No data to support improved compliance with anti-retroviral therapies in HIV (+) patients.
Egrifta Wr Dosage and Administration
Adult
Give by SC inj into abdomen; rotate inj sites. 1.28mg (0.16mL) once daily.
Children
Not established.
Administration
Must be reconstituted with diluent provided. Inject SC into skin of abdomen; rotate inj sites.
Egrifta Wr Contraindications
Contraindications
Disruption of hypothalmic-pituitary axis due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation, or head trauma. Active malignancy. Pregnancy.
Egrifta Wr Boxed Warnings
Not Applicable
Egrifta Wr Warnings/Precautions
Warnings/Precautions
Egrifta WR and Egrifta SV are not substitutable. Increased risk of neoplasms. History of treated and stable malignancies. Fluid retention. Monitor IGF-1 levels closely; consider discontinuing if IGF-1 levels persistently elevated (eg, >3 SDS). Increased risk of impaired glucose tolerance or diabetes. Evaluate glucose status prior to initiation; monitor for changes in glucose metabolism. Monitor for worsening retinopathy in diabetic patients. Discontinue in critically ill patients. Nursing mothers: not recommended.
Egrifta Wr Pharmacokinetics
Absorption
Median peak plasma concentration (Tmax): 0.15 hour.
Distribution
Volume of distribution: 4.8±1.9 L/kg (after the 1.28mg dose).
Elimination
Half-life: 11 minutes (after the 1.28mg dose).
Egrifta Wr Interactions
Interactions
Caution with concomitant drugs metabolized by CYP450 (eg, corticosteroids, sex steroids, anticonvulsants, cyclosporine). May inhibit 11β-hydroxysteroid dehydrogenase type 1; may need to increase maintenance or stress doses of glucocorticoid, if needed for replacement in hypoadrenalism.
Egrifta Wr Adverse Reactions
Adverse Reactions
Arthralgia, inj site erythema/pruritus, extremity pain, peripheral edema, myalgia, carpal tunnel syndrome; glucose intolerance, diabetes, hypersensitivity reactions.
Egrifta Wr Clinical Trials
See Literature
Egrifta Wr Note
Not Applicable
Egrifta Wr Patient Counseling
See Literature